Transcatheter Tricuspid Valve Replacement Using the Medtronic Intrepid™ TTVR System in Patients With Severe Symptomatic Tricuspid Regurgitation - PATHFINDER
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years at the time of consent.
• Severe symptomatic tricuspid regurgitation (TR) despite optimal medical therapy (OMT).
• Local site multidisciplinary heart team experienced in tricuspid valve therapies agrees that the subject is appropriate for TTVR.
Locations
United States
Arizona
Abrazo Arizona Heart Hospital
RECRUITING
Phoenix
California
Los Robles Hospital & Medical Center
RECRUITING
Thousand Oaks
Minnesota
Abbott Northwestern Hospital
RECRUITING
Minneapolis
Ohio
The Christ Hospital
RECRUITING
Cincinnati
Contact Information
Primary
Amber St Martin
rs.pathfinder@medtronic.com
612-380-5637
Time Frame
Start Date: 2026-08
Estimated Completion Date: 2041-04
Participants
Target number of participants: 1186
Treatments
Experimental: Medtronic Intrepid™ TTVR
Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation.
Active_comparator: Edwards EVOQUE TTVR
Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR in patients with severe or greater tricuspid regurgitation.
Experimental: Single Arm Registry
Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation who are not eligible for randomization.
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiovascular